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Investigation of the effects of tirzepatide (Mounjaro)

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	type2 diabetes
Date of first enrollment	2024/08/28
Target sample size	16
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	administrate tirzepatide starting at a dose of 2.5 mg once weekly, the dose being increased to 5 mg after four weeks and maintained until the study endpoint at 12 weeks.

Outcome(s)

Primary Outcome	Change in glucose infusion required rate in the hyperinsulinemic-euglycemic clamp analysis from baseline to 12 weeks after the start of tirzepatide
Secondary Outcome	changes in HbA1c, fasting plasma glucose, body weight, body composition (muscle mass, fat mass, fat percentage), fasting lipid profile (triglycerides, HDL cholesterol, LDL cholesterol), fasting glucagon levels, HOMA2-IR, HOMA2-%be-ta, and the correlations between the changes of these measurements and glucose infusion required rate.

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	74years-old
Gender	Male and Female
Include criteria	1) type2 diabetes 2) baseline HbA1c level < 12.0% 3) BMI >=25 kg/m2 4) with or without metformin monotherapy at a stable dose
Exclude criteria	(i) diagnosis of type 1 diabetes or other type of diabetes, (ii) hypoglycemic agent other than metformin, (iii) medication or disease affecting glycemic management or body composition (corticosteroids, thyroid disease, malignancy, etc.), (iv) hospitalization within the observation period, (v) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase level >=2 times the normal upper limit), (vi) renal dysfunction (estimated glomerular filtration rate of <45 mL/min/1.73 m2), (vii) severe cardiac dysfunction (New York Heart Association class>II), (viii) judgment by the researchers for any other reason of ineligibility to participate